The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Ca-1000/sysmex Ca-5000.
| Device ID | K964946 |
| 510k Number | K964946 |
| Device Name: | SYSMEX CA-1000/SYSMEX CA-5000 |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Contact | Margaret Barranco, Ma, Mt (ascp) |
| Correspondent | Margaret Barranco, Ma, Mt (ascp) SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-10 |
| Decision Date | 1997-03-18 |
| Summary: | summary |